MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MINIBUNION; Plate, fixation, bone

Model Number	3100-2716NL
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following lot history record of the sterile implant and individual component part were reviewed in their entirety during the investigation.These records include quality inspection procedures, component inspection records, component print specifications, component supplier certificates of conformance, supplier inspection certificates, raw material certificates of conformance, and supplier certificates of compliance.No non-conformances were found in any of these records that were reviewed.Description, part number, lot number: minibunion non-locking screw 3.0mm x 24mm - sterile kit, 3100-2716nl, 5000720; minibunion non-locking screw 3.0mm x 24mm component, 280246, 103484.
Event or Problem Description
Doctor performed a minibunion surgery on (b)(6) 2019.At 13 weeks post-operation during a follow-up visit on (b)(6) 2019, an x-ray revealed a broken non-locking screw in a minibunion plate.There is no resolution to date for this case.Doctor reports that the patient is doing fine, and he has no plans to revise this patient or remove hardware.

• Brand Name: MINIBUNION
• Common Device Name: Plate, fixation, bone
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6423 shelby view dr.; suite 101; memphis TN 38134
• Manufacturer Contact: 6423 shelby view dr; suite 101; memphis, TN 38134 ; 9012218406
• MDR Report Key: 15501697
• Report Number: 3020584246-2022-00037
• Device Sequence Number: 20772279
• Product Code: HRS
• UDI-Device Identifier: 00815432027026
• UDI-Public: 00815432027026
• Combination Product (Y/N): N
• PMA/510(K) Number: K181872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/03/2021
• Device Model Number: 3100-2716NL
• Device Catalogue Number: 3100-2716NL
• Device Lot Number: 500720
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male